FDA cracks down on pill’s lifestyle claims

To some of us it may seem that the contraceptive pill has always promised too much. It’s chief claim, “99 per cent effective in preventing pregnancy when taken as directed”, depends on reading all the fine print, knowing all your contra-indications and never missing a day. But how many women do all that? Even granted that it prevents pregnancy, many women have been disillusioned by side effects ranging from weight gain to cancer risks, and have given up taking the pill.

However, the pill remains the chief method of birth control for younger women. It’s a very competitive market. So along came a new variety from drug giant Bayer with the catchy name of Yaz, marketed on television as a lifestyle drug for the 20-somethings, with promises to improve a woman’s mood and clear up acne -- oh, and prevent pregnancy 99 per cent of the time (if taken as directed). “We’re not gonna take it,” sang the smartly-dressed gals in one commercial as they kicked away balloons with labels such as “irritability” and “feeling anxious”. In two years Yaz -- “A pill that goes beyond the rest” -- became the best-selling oral contraceptive in the US, with sales last year of $616 million or about 18 per cent market share.

Trouble was, the ads hyped the lifestyle features too much and made it look like a specific remedy for premenstrual syndrome and acne, when it was only indicated for serious forms of those malaises in women who were prescribed it primarily for birth control. The commercials also failed to warn of serious risks for some women taking Yaz because it contains a progestin that can increase potassium levels -- bad news for women with certain diseases or taking a variety of drugs.

Last October the Federal Drug Administration, which had approved Yaz in 2006, sent Bayer a letter warning them that the TV ads overstated the drug’s benefits while understating its risks. The FDA subsequently ordered the company to submit a media plan for a corrective message that would reach the same size and kind of TV audiences as the misleading ads did. And so it happens that Bayer is now running a $20 million ad campaign warning that nobody should take Yaz hoping it will cure pimples or PMS. Even so, says one expert observer, that is small change for an outfit like Bayer, “just the cost of doing business”. Despite the fact that Bayer has to submit all new direct to consumer ads for Yaz for FDA vetting, it could be business as usual again soon in the world of contraception marketing. ~ New York Times, Feb 10



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